Events

Recall of Newport HT70 and HT70 Plus Ventilators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Covidien Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00467-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-04-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00467-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Medtronic have received reports that newport ht70 and newport ht70 plus ventilators may reset spontaneously during normal operation, without an accompanying alarm. following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. the reported incidence of the reset without alarm condition is approximately one (1) reset in every 7 million hours of ventilation. while the reports indicated that patients required transfer to another ventilator, no patient injury or impairment has been reported. there have been no reports of adverse events in australia.
  • Action
    Medtronic will provide a software update to resolve the issue, with expected availability end of May 2017. In the interim, an alternative ventilator should be used for patients who are ventilator dependent and have severe lung injury, and all other users should access alternative ventilators where possible and until the corrective actions can be implemented. If the Newport HT70 or Newport HT70 Plus ventilators are to be used, users are to ensure patients on ventilators are appropriately monitored by trained caregivers as described in Operator’s Manual and as detailed in the customer letter.

Device

Newport HT70 and HT70 Plus Ventilators

Manufacturer

Covidien Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA